Rectal Band Ligation Device And Method Of Operation Thereof

ABSTRACT

A rectal band ligation device and a method of operating the band ligation device. In one embodiment, the band ligation device includes: (1) a handle having a trigger associated therewith, (2) an extension tube extending from the handle and terminating in a head, (3) at least two openings in the head, (4) hollow pistons located in the openings and configured to move relative thereto between an extended position in which ends of the pistons are exposed through the openings and a retracted position, gaps between corresponding openings and hollow pistons being less than cross-sectional widths of elastic members stretched around the ends and (5) an actuating rod coupling the trigger and the pistons and configured to cause the pistons to move from the extended position to the retracted position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional of U.S. patent application Ser. No.15/782,377, filed Oct. 12, 2017, which claims priority based on U.S.Provisional Patent Application Ser. No. 62/408,302, filed on Oct. 14,2016, and entitled “Rectal Injection Device and Methods of Manufactureand Operation Thereof,” commonly owned with this application andincorporated herein by reference.

TECHNICAL FIELD

This application is directed, in general, to a band ligation device and,more specifically, to a rectal band ligation device for hemorrhoids andmethods of manufacturing and operating the same.

BACKGROUND

Every year hundreds of millions of individuals worldwide suffer fromserious lower gastrointestinal (GI) diseases and disorders (e.g., fecalanal incontinence/laxity, hemorrhoids, colitis) requiring intervention.The technology incorporated in the design of gastrointestinal deviceshas seen little to no developmental progress in recent years. Indeed,biopsy forceps, polypectomy snares and fine aspiration needles have seenso little change that they are becoming commodities. Though theseconventional devices remain limited in their efficacy, the incidence ofthese disease states continues to increase.

Many other GI disorders have a major impact on health. For example,hemorrhoids—inflamed and swollen veins in the anus or lower rectum—areextremely common, accounting for some 50 million procedures performedworldwide. The two most common office-based procedures used to treatsymptomatic hemorrhoids are rubber band ligation (RBL) and sclerotherapy(SCL). RBL involves stretching an elastomeric band (that need not berubber) about a target vein so that it constricts and substantiallyhalts blood flow through the vein, causing it to shrivel over time, thusreducing and eliminating the hemorrhoid.

SUMMARY

One aspect provides a rectal band ligation device. In one embodiment,the band ligation device includes: (1) a handle having a triggerassociated therewith, (2) an extension tube extending from the handleand terminating in a head, (3) at least two openings in the head, (4)hollow pistons located in the openings and configured to move relativethereto between an extended position in which ends of the pistons areexposed through the openings and a retracted position, gaps betweencorresponding openings and hollow pistons being less thancross-sectional widths of elastic members stretched around the ends and(5) an actuating rod coupling the trigger and the pistons and configuredto cause the pistons to move from the extended position to the retractedposition.

In another embodiment, the band ligation device includes: (1) a handlehaving a trigger associated therewith, (2) an extension tube extendingfrom the handle and terminating in a head, the head being of largerdiameter than the extension tube and configured to seat on an analdentate of a rectum, (3) at least two openings in the head, (4) hollowpistons located in the openings and configured to move relative theretobetween an extended position in which ends of the pistons are exposedthrough the openings and a retracted position, gaps betweencorresponding openings and hollow pistons being less thancross-sectional widths of elastic members stretched around the ends and(5) an actuating rod coupling the trigger and the pistons and configuredto cause the pistons to move from the extended position to the retractedposition.

Another aspect provides a method of operating a rectal band ligationdevice. In one embodiment, the rectal band ligation device includes: (1)inserting a head of the device into a rectum of an animal, (2) creatinga suction within the head to cause tissue in the rectum to enter thehead through multiple openings thereof and (3) releasing elastic bandssurrounding at least some of the openings onto the tissue, causing theelastic bands to bear upon and constrict blood flow to the tissue.

BRIEF DESCRIPTION

Reference is now made to the following descriptions taken in conjunctionwith the accompanying drawings, in which:

FIG. 1 is an isometric view of one embodiment of a rectal band ligationdevice;

FIG. 2 is a partial lateral sectional view of the rectal band ligationdevice of FIG. 1;

FIG. 3 is an axial sectional view of the rectal band ligation device ofFIG. 2; and

FIG. 4 is a flow diagram of one embodiment of a method of using a rectalband ligation device.

DETAILED DESCRIPTION

Introduced herein are various embodiments of a device and method forperforming RBL to address hemorrhoids or other concerns. A deviceproviding for RBL for the treatment of hemorrhoidal tissue is alsodescribed herein. The device is capable of treating multiple separatesites concurrently and without the need for visualization. In otherwords, the clinician does not need to see the target area to operate onit.

The band ligation device and method may be used in a form integratedwith the injection array device described in co-pending patentapplication Ser. No. 15/625,552 filed on Jun. 16, 2017, by Markle, etal., and entitled “Rectal Injection Device and Method of OperationThereof,” commonly owned with this application and incorporated hereinby reference. In the case where an integrated version of the device isused, the advantage to the practitioner and the patient is the abilityto provide both RBL and sclerotherapy (SCL) to the hemorrhoidal tissuein a single procedure, minimizing discomfort and the need for repeatedprocedures and appointments. The use of the integrated version may bemost suitable to more severe cases of hemorrhoids, where neither bandingnor SCL alone provide adequate treatment of the condition.

Many of the various band ligation device embodiments are used asfollows: (1) a head of the device is inserted into the rectum of asubject animal or human past the anal dentate line; (2) suction iscreated within the head to cause tissue in the rectum to enter the headthrough multiple openings thereof; (4) elastic bands surrounding atleast some of the openings are released onto the tissue, causing them tobear upon and constrict blood flow to the tissue; and (5) the device iswithdrawn. Constriction of the blood flow effects the treatment, whetherit be for hemorrhoids or another condition. In certain embodiments, thehead is or becomes enlarged in terms of its diameter such that it seatsagainst the internal sphincter. This allows a clinician operating thedevice some assurance that the head is properly located within thepatient without needing to see the head, e.g., using a scope). Ofcourse, a scope may be employed.

In certain embodiments, the head is bulbous. In other embodiments, thehead is conical or frustoconical.

In certain other embodiments, the multiple openings are evenly spacedcircumferentially about the head, to cause the elastic bands to treatevenly spaced regions of the rectum with a single pass. In otherembodiments, the openings are irregularly spaced.

In some embodiments, the openings lie in single plane normal to a majoraxis of the device. In other embodiments, the openings are not confinedto a single plane and may be distributed about the head in variouslocations.

In one embodiment, the head has only two openings. Other embodimentscontain more, and perhaps many more, openings.

In certain embodiments, hollow pistons extend into the openings and areemployed to hold the elastic bands. After suction urges tissue to enterthe openings and the hollow pistons, the pistons may then be retracted,which urges the elastic bands off the pistons and onto the tissue,thereby carrying out RBL. In one embodiment, an actuating rod may rotateor translate to cause the pistons to retract and the elastic bands to bedeployed. In other embodiments, the needles rotate to deploy andretract. In some embodiments, the pistons are spring-loaded so that theyretract in the absence of another force.

In many embodiments, the actuating rod is common to all pistons in agiven device. In other embodiments, multiple actuating rods or actuatorsmay allow elastic bands to be deployed individually or in subsets.

In another embodiment, an optical endoscopic functionality may beintegrated with the ligation device to aid in the accurate location ofRBL sites, and to provide visualization of the RBL site duringdeployment of elastic bands. A sufficiently low-cost camera may be usedin this integration to enable the cost-effective one-time-use of thedevice.

In another embodiment, the device may be used for the purpose ofproviding for SCL for esophageal varices.

FIG. 1 is an isometric view of a linear embodiment of a rectal bandligation device 100. The device 100 has an elongated handle 110, anextension tube 120 extending from the handle 110 and a head 130. Thehandle 110 is configured to be gripped by a human hand. The head 130 isconfigured to be inserted into a rectum of an animal, which may be ahuman, treat the rectum with RBL via a plurality of elastic bands (notshown in FIG. 1) and be withdrawn from the rectum.

In the illustrated embodiment, the head 130 is bulbous. The extensiontube 120 supports the head relative to the handle 110. A trigger 140extends laterally from the handle and is configured to be moved to causetissue (which may be hemorrhoidal or proximate hemorrhoidal tissue) tobe drawn into openings (not shown) in the head 130 and banded. In theillustrated embodiment, the trigger 140 is located beneath the handle110 and configured to be translated away from the head 130 to cause asuction to be drawn through the openings and thereby cause tissue to bedrawn into the openings. An RBL button 150 also extends laterally fromthe handle and is configured to be depressed to perform RBL with respectto the tissue. In the illustrated embodiment, the RBL button 150 isopposite the handle 110 from the trigger 140, and therefore over thehandle 110, as shown.

Two indicators are shown in the handle 110. From left to right, theyare: a suction indicator 160 configured to indicate whether or not asuction sufficient for RBL has been drawn and an elastic band deploymentindicator 170 configured to indicate whether or not RBL has beenperformed.

As illustrated in FIGS. 2 and 3, the band ligation device includes ahead 201 which is at least somewhat hollow, and multiple openings 202 inthe head 201, in which tissue 209 may be drawn into such openings 202via suction, e.g., drawn through a suction port 206, for the purpose ofperforming RBL of the tissue 209. Elastic bands 203 are positionedaround the circumference of the openings 202 by means of being placed ona hollow piston 204 before using the device 100. The piston 204 movesinside a sleeve 205, and is drawn inward after the tissue 209 has beendrawn into the opening 202 via suction, causing the elastic band 203 torelease and engage the tissue 209. The suction may be provided by aplunger (not shown) that may be withdrawn to create a partial vacuum, bymeans of a vacuum hose or line (not shown) powered externally providinga partial vacuum or by other means in which a partial vacuum may becreated. Those ordinarily skilled in the pertinent art will understandvarious ways to create a suction in the device 100 of FIG. 1.

As is apparent in FIG. 2, a gap 211 exists between an inner surface ofthe sleeve 205 (which defines the opening) and an outer surface of thepiston 204. This gap 211 is less than a cross-sectional width 212 of theelastic band 203. This is to force the elastic band 203 off the end ofthe piston 204 and onto the tissue 209 as the piston 204 retracts,rather than allow the elastic band 203 to enter the gap and retract withthe piston 204.

In the embodiment of the RBL or combination device illustrated in FIGS.2 and 3, to release the elastic bands 203 positioned around the pistons204, the pistons 204 are drawn radially inwards towards the axis of thehead 201 by mechanical, hydraulic, or electrical means, causing theelastic bands 203 to be released onto the tissue 209 as they are pulledagainst the exterior of the head 201. The head 201 may include recesses210 to allow for placement of the elastic bands 203 on the outside ofthe piston 204. In one embodiment, the pistons 204 may be actuated todraw inwards by means of a cam mechanism or linkage (comprisingconnecting rods 208 flexibly coupled to the pistons 204 and a rotatableactuating rod 213 positioned at or proximate the axis of the head 201 byrespective hinges 207, 214. In the case of the band ligation deviceintegrated with an injection device, the cam mechanism or linkage may besituated on a sleeve (not shown) containing an actuation mechanism forthe injector needles and tubes transporting the sclerosing agent.Rotation of the actuating rod 213 may be actuated by the practitionerfrom the handle of the device and may be coupled to a trigger (e.g., thetrigger 140 of FIG. 1) or other mechanism to provide for rotation. In analternative embodiment, the actuating rod 213 may be translated alongthe axis of the head 201 similarly to draw the pistons 204 radiallyinwardly.

The head of the RBL or combination device is inserted into the rectum ofthe patient and is positioned in a manner such that the opening(s) 202in the head 201 are proximate to the tissue 209 which is to be drawninto the openings 202 and into the pistons 204 for banding.

The RBL or combination SCL/RBL device may be used as a disposable form,or may be fabricated from materials suitable for sterilization, and bereused following cleaning and sterilization.

The RBL or combination SCL/RBL device may be fabricated from transparentmaterials, e.g., transparent plastic such as polycarbonate, allowing forthe placement of a suitable camera, or cameras, with illumination, inthe interior of the device, to enable viewing and positioning of thedevice by the practitioner during its use. In the case where one or morecameras are positioned inside the device, having suitable transparency,the source of illumination may be positioned at an oblique angle to thesurface of the transparent walls of the device relative to the cameraposition, to minimize specular reflection. Components in the interior ofthe device may be provided with a matte black finish to minimizeunwanted reflections of the illumination. When used with such camera orcameras, the device may comprise an injection array device, a bandligation device, or a combination device with both functionalities.

The RBL or combination SCL/RBL device may be used in a “blind” mode, inwhich the location of the tissue is determined in advance by thepractitioner, and the device is positioned in the approximate locationrequired for banding of such tissue, or it may be used in a guided modewith vision provided by camera(s) as described above. Typically betweenone and six bands may actually be applied during used of the device.

FIG. 4 is a flow diagram of one embodiment of using a rectal bandligation device. The method begins in a start step 410. In a step 420, ahead of the device is inserted into a rectum of an animal. In a step430, a suction is created within the head to cause tissue in the rectumto enter the head through multiple openings thereof. In a step 440,elastic bands surrounding at least some of the openings onto the tissueare released. This causes the elastic bands to bear upon and constrictblood flow to the tissue. The device may then be withdrawn from therectum. The method ends in an end step 450.

Those skilled in the art to which this application relates willappreciate that other and further additions, deletions, substitutionsand modifications may be made to the described embodiments.

1. A rectal band ligation device, comprising: a handle having a triggerassociated therewith; an extension tube extending from said handle andterminating in a head; at least two openings in said head; hollowpistons located in said openings and configured to move relative theretobetween an extended position in which ends of said pistons are exposedthrough said openings and a retracted position, gaps betweencorresponding openings and hollow pistons being less thancross-sectional widths of elastic members stretched around said ends;and an actuating rod coupling said trigger and said pistons andconfigured to cause said pistons to move from said extended position tosaid retracted position.
 2. The device as recited in claim 1 whereinsaid actuating rod rotates to cause said hollow pistons to move towardsaid retracted position.
 3. The device as recited in claim 1 whereinsaid actuating rod translates to cause said hollow pistons to movetoward said retracted position.
 4. The device as recited in claim 1wherein a surface of said head is configured to seat on an anal dentateof a rectum.
 5. The device as recited in claim 1 wherein said openingsare evenly spaced in said head.
 6. The device as recited in claim 1further comprising an RBL button extending laterally from said handleand configured to be depressed to perform ligation with respect to saidtissue.
 7. The device as recited in claim 1 further comprising a suctionindicator associated with said handle and configured to indicate whetheror not a suction sufficient for ligation has been drawn.
 8. The deviceas recited in claim 1 further comprising an elastic band deploymentindicator associated with said handle and configured to indicate whetheror not ligation has been performed.
 9. The device as recited in claim 1wherein said head is of larger diameter than said extension tube. 10.The device as recited in claim 1 wherein said openings lie in singleplane normal to a major axis of said device.
 11. A method of operating arectal band ligation device, comprising: inserting a head of said deviceinto a rectum of an animal; creating a suction within said head to causetissue in said rectum to enter said head through multiple openingsthereof; and releasing elastic bands surrounding at least some of saidopenings onto said tissue, causing said elastic bands to bear upon andconstrict blood flow to said tissue.
 12. The method as recited in claim11 wherein said releasing comprises causing an actuating rod to rotateto cause hollow pistons in said head to move toward a retractedposition.
 13. The method as recited in claim 11 wherein said releasingcomprises causing an actuating rod to translate to cause hollow pistonsin said head to move toward a retracted position.
 14. The method asrecited in claim 11 further comprising pulling back said head to causesaid head to seat against an anal dentate of said rectum, a surface ofsaid head being configured to seat on said anal dentate.
 15. The methodas recited in claim 11 wherein said openings are evenly spaced in saidhead.
 16. The method as recited in claim 11 further comprisingdepressing an rectal band ligation button to perform ligation withrespect to said tissue.
 17. The method as recited in claim 11 furthercomprising indicating whether or not a suction sufficient for ligationhas been drawn.
 18. The method as recited in claim 11 further comprisingindicating whether or not ligation has been performed.
 19. The method asrecited in claim 11 wherein said head is of larger diameter than saidextension tube and said openings lie in a single plane normal to a majoraxis of said device.
 20. A rectal band ligation device, comprising: ahandle having a trigger associated therewith; an extension tubeextending from said handle and terminating in a head, said head being oflarger diameter than said extension tube and configured to seat on ananal dentate of a rectum; at least two openings in said head; hollowpistons located in said openings and configured to move relative theretobetween an extended position in which ends of said pistons are exposedthrough said openings and a retracted position, gaps betweencorresponding openings and hollow pistons being less thancross-sectional widths of elastic members stretched around said ends;and an actuating rod coupling said trigger and said pistons andconfigured to cause said pistons to move from said extended position tosaid retracted position.